Vascular Impact of Dapagliflozin in CKD Patients (DAPAVASC)
NCT ID: NCT04930549
Last Updated: 2021-10-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
54 participants
INTERVENTIONAL
2021-12-31
2023-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Dapagliflozin 10Mg Tab
Dapagliflozin 10 mg film-coated tablets
Dapagliflozin 10Mg Tab
Patients receive dapagliflozin 10mg tablets once a day during 12 weeks
impedance cardiography
impedance cardiography (PhysioFlow® PF-05 Lab1TM, Manatec Biomedical) is done for evaluation of cardiac function
Applanation tonometry
Applanation tonometry will be done using SphygmoCor®, Hogimed) is done for evaluation of arterial stiffness
post-ischemic hyperemia of forearm
An arterial occlusion cuff will be placed on the forearm, and will be deflated to allow post-ischemic hyperemia with the continuous measurements of brachial artery diameter and blood flow velocity by high-resolution echotracking coupled to a Doppler system (ArtLab system®)
haemodynamics parameters
haemodynamics parameters will be evaluated using automatic oscillometric recorder
Placebo
Identical film-coated tablets without dapagliflozin
Placebo
Patients receive placebo tablets once a day during 12 weeks
impedance cardiography
impedance cardiography (PhysioFlow® PF-05 Lab1TM, Manatec Biomedical) is done for evaluation of cardiac function
Applanation tonometry
Applanation tonometry will be done using SphygmoCor®, Hogimed) is done for evaluation of arterial stiffness
post-ischemic hyperemia of forearm
An arterial occlusion cuff will be placed on the forearm, and will be deflated to allow post-ischemic hyperemia with the continuous measurements of brachial artery diameter and blood flow velocity by high-resolution echotracking coupled to a Doppler system (ArtLab system®)
haemodynamics parameters
haemodynamics parameters will be evaluated using automatic oscillometric recorder
Interventions
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Dapagliflozin 10Mg Tab
Patients receive dapagliflozin 10mg tablets once a day during 12 weeks
Placebo
Patients receive placebo tablets once a day during 12 weeks
impedance cardiography
impedance cardiography (PhysioFlow® PF-05 Lab1TM, Manatec Biomedical) is done for evaluation of cardiac function
Applanation tonometry
Applanation tonometry will be done using SphygmoCor®, Hogimed) is done for evaluation of arterial stiffness
post-ischemic hyperemia of forearm
An arterial occlusion cuff will be placed on the forearm, and will be deflated to allow post-ischemic hyperemia with the continuous measurements of brachial artery diameter and blood flow velocity by high-resolution echotracking coupled to a Doppler system (ArtLab system®)
haemodynamics parameters
haemodynamics parameters will be evaluated using automatic oscillometric recorder
Eligibility Criteria
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Inclusion Criteria
* Age ≥ 18 years
* Receiving a stable dose of an ACE inhibitor or ARB for at least 12 weeks before screening or patients who were documented to be intolerant to ACE inhibitors or ARBs
Exclusion Criteria
* Recessive or autosomal dominant polycystic kidney disease
* Anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis
* Lupus nephritis
* Receiving cytotoxic therapy, immunosuppressive therapy or other immunotherapy for primary or secondary renal disease within 6 months prior to enrolment
* History of organ transplantation
* Body weight \> 35 kg/m²
* Receiving therapy with a sodium glucose co-transporter 2 (SGLT2) inhibitor within 8 weeks prior to enrolment or previous intolerance of an SGLT2 inhibitor
* Patients with NYHA class IV congestive heart failure at the time of enrolment
* Myocardial infarction, unstable angina, stroke or transient ischemic attack (TIA) within 12 weeks prior to enrolment
* Coronary revascularization (percutaneous coronary intervention or coronary artery bypass grafting) or valvular repair/replacement within 12 weeks prior to enrolment or is planned to undergo any of these procedures after randomization
* Active malignancy requiring treatment at the time of enrolment or is planned to undergo any treatment after randomization
* Severe hepatic impairment (Child-Pugh class C)
* History of frequent genital mycotic infections (\>2)
* Current pregnancy OR women of child-bearing potential (ie, those who are not chemically or surgically sterilized or who are not post-menopausal) who are not willing to use a medically accepted method of contraception that is considered reliable in the judgment of the investigator OR women who have a positive pregnancy test at enrolment or exploration visits OR women who are breast-feeding
* Contraindications to use glyceryl trinitrate (in particular allergy to nitrates or concomitant use of vasodilators)
* Participation in another clinical study with an investigational product during the last month prior to enrolment
* Inability of the patient, in the opinion of the investigator, to understand and/or comply with procedures and/or follow-up OR any conditions that, in the opinion of the investigator, may render the patient unable to complete the study.
18 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
University Hospital, Rouen
OTHER
Responsible Party
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Principal Investigators
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Dominique Guerrot, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Rouen
Jeremy Bellien, PharmD, PhD
Role: STUDY_DIRECTOR
University Hospital, Rouen
Locations
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Department of Nephrology
Bois-Guillaume, , France
Department of Pharmacology
Rouen, , France
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2021/0188/HP
Identifier Type: -
Identifier Source: org_study_id